Results of the Postmarket Clinical Study of the Sientra 207 Highly Cohesive Gel Breast Implants in Primary and Revision Augmentation.

BACKGROUND: Board-certified plastic surgeons utilizing the Sientra 207 Highly Cohesive Gel breast implants provided their initial satisfaction with usage and postoperative results on primary and revision augmentation patients, and study participants provided their satisfaction with surgical result.

METHODS: Up to 15 participating investigators at institutional review board-approved sites enrolled up to 180 women who received Sientra 207 implants for primary augmentation or revision augmentation procedures. Investigator and participant assessments were performed preoperatively and postoperatively at 3, 6, and 12 months.

RESULTS: All participating surgeons found the implants to be easy or very easy to implant, and 92 percentage reported satisfaction with surgical results. Patients receiving these implants reported similarly high rates of satisfaction (94%).

CONCLUSION: With this combination of high satisfaction and low complication rates, the Sientra 207 silicone breast implants now provide a welcome addition to plastic surgeons' breast implant options.